Guidewire and method for surgical procedures

ABSTRACT

A surgical guide wire or K-wire and method of use are provided. The K-wire, or guide wire, has opposite end portions and a shank portion in between. One end portion has a deformable end portion that, once outside of a confining guide passage, can be deformed to present a projected forward facing area that is larger than the transverse cross section of the K-wire, or guide wire, while in the passage. The increased area will provide increased resistance to additional forward axial movement into the surgical site.

CROSS REFERENCE TO RELATED APPLICATIONS

In accordance with 37 C.F.R 1.76, a claim of priority is included in anApplication Data Sheet filed concurrently herewith. Accordingly, under35 U.S.C. §119(e), 120, 121, and/or 365(c) the present invention claimspriority as a continuation of U.S. patent application Ser. No.13/973,677; filed Aug. 22, 2013, entitled, “GUIDEWIRE AND METHOD FORSURGICAL PROCEDURES”, which is a continuation-in-part to U.S.Non-Provisional application Ser. No. 13/722,667; filed Dec. 20, 2012,entitled, “GUIDEWIRE AND METHOD FOR SURGICAL PROCEDURES”, now U.S. Pat.No. 8,540,676, issued Sep. 24, 2013, which is a continuation-in-part toU.S. Non-Provisional application Ser. No. 13/037,947, filed Mar. 1,2011, entitled, “GUIDEWIRE AND METHOD FOR SURGICAL PROCEDURES”, now U.S.Pat. No. 8,545,531, issued Oct. 1, 2013, which is a continuation-in-partof U.S. Non-Provisional Utility application Ser. No. 12/823,791, filedJun. 25, 2010, entitled, “K-WIRE AND METHOD FOR SURGICAL PROCEDURES”,now U.S. Pat. No. 8,361,102, issued Jan. 29, 2013, which claims priorityto U.S. Provisional Application No. 61/220,828, filed Jun. 26, 2009,entitled, “K-WIRE AND METHOD FOR SURGICAL PROCEDURES”. The contents ofeach of the above referenced applications are herein incorporated byreference in its entirety.

FIELD OF INVENTION

The present invention relates to an improved guide wire or K-wire foruse in surgical procedures such as orthopedic procedures; and inparticular, to spinal procedures such as percutaneous pedicle screwconstructs.

BACKGROUND OF THE INVENTION

In certain surgical procedures, a K-wire (Kirschner wire) or guide wireis used in combination with a surgical tool, such as a jamshidi needle.The jamshidi needle is generally used to form a hole through bone as afirst step in certain medical procedures, such as attaching a screw to apedicle. The K-wire, or guide wire, is inserted through the cannula ofthe jamshidi sheath into the interior of the bone. This procedure, ifnot completed properly can injure the patient, particularly if itengages certain sensitive parts which may include breaching the anteriorcortex of a vertebral body. The K-wire, or guide wire, is used as aportal for certain surgical steps like guiding a drill, tap, screw,screwdriver or the like to the surgical site. The procedures oftentimesrequire the use of force which can cause a properly positioned K-wire,or guide wire, to move forward into or through the surgical site; which,if excessive, can move into contact where contact is to be avoided.

A K-wire, or guide wire, includes a generally elongated cylindricalshape and has a preferred diameter of about 1.3 millimeters, althoughthe diameter can vary depending on the procedure and hardware beingutilized for the procedure. The cross sectional size and shape of theK-wire is limited only by the tools and devices it is used with. Eachtool or device is typically provided with a through bore for receivingthe K-wire, or guide wire, limiting the size and type of wire that canbe used. Additionally, the K-wire is typically removed by passagethrough a through bore in a device or tool. Thus, to date, only K-wireswith a small diameter, generally cylindrical round cross section, havebeen used; which presents the problem in their use. The relatively smalldiameter, combined with a lack of impeded movement, allows movementduring a surgical procedure. Such movement is often difficult to noticeduring a surgical procedure where vision is limited by fluids, tissueand/or bone, and may further require x-rays or the like to determine theposition of the wire. It should also be noted that while the K-wires, orguide wires, illustrated herein include a solid center core, the K-wire,or guide wire, may be a hollow tubular member without departing from thescope of the invention.

The present invention provides various solutions to this problem byproviding an improved K-wire, or guide wire, which, when inserted,provides increased resistance to forward axial movement while stillbeing usable with traditional surgical tools and devices.

The present invention also provides easy removal of the K-wire, or guidewire, through traditional surgical tools and devices.

DESCRIPTION OF THE PRIOR ART

U.S. Pat. No. 5,431,651 discloses a cross pin and set screw femoral andtibial fixation device for mounting a ligament graft. The deviceincludes a drill guide for drilling a transverse hole. The drill guideis releasable from a first twist drill so as to leave it in place. Thefirst twist drill is used to guide further drilling and passage of afastener device. A K-wire or the first twist drill is used for guiding asecond twist drill for enlarging the transverse hole and for guiding andturning a cannulated fastener device into a femoral bone end of theligament graft. There is no feature on the K-wire to limit the extent ofits insertion subsequent to it passing through the bone.

U.S. Pat. No. 7,575,578 discloses a surgical drill guide including ahandle and an arm having an end which contacts a bone. The handleincludes a plurality of slots or channels which receive a sleeve. Thesleeve is used to guide a K-wire into the bone. The K-wire serves as aguide for drilling a tunnel into the bone. The K-wire does not include afeature to limit the extent of its insertion subsequent to it passingthrough the bone.

U.S. Published Patent Application No. 2007/0239159 discloses devices andsystems for placing bone stabilization components in an individual. Inparticular, the bone stabilization components are placed on the spine.Various tools, including a K-wire, are employed to properly locate,place and secure the devices in an individual.

U.S. Published Patent Application No. 2007/0270896 discloses a devicefor accessing the pedicle of a vertebra including a Jamshidi needle.

SUMMARY

The present invention involves the provision of a K-wire which can beused with traditional surgical tools and devices. The inventive guidewire or K-wire has an end portion that, upon exit from the through boreof a surgical tool or device, can be changed in a controlled manner topresent a deformable end portion that will provide a forward face with alarger projected area than the end surface of the K-wire while in thethrough bore. The deformation may be induced mechanically, from internalstress, thermally or otherwise.

The present invention also involves the provision of a method ofconducting surgery utilizing a guide wire, or K-wire. The methodincludes passing a guide wire or K-wire through a tool or device into asurgical opening with the guide wire, or K-wire, presenting a forwardfacing area of a first size. The guide wire, or K-wire, then has an endportion, when moved out of the tool or device, where the forward endportion can be expanded to present a forward facing area of a secondsize larger than the first size. After use, the guide wire or K-wire maybe extracted from the surgical site through a surgical tool or device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic plan view of vertebra showing a jamshidi needleextending through a pedicle;

FIG. 2A is a side elevation view of a typical prior art K-wire, or guidewire, having a straight cylindrical body and forward face;

FIG. 2B is a side elevation view of one embodiment of a K-wire, or guidewire, of the instant invention showing an end configuration that curlsto create an enlarged end face to resist forward migration;

FIG. 3 is an enlarged fragmentary view of a K-wire, or guide wire,showing an end portion configured to present an expanded forward face;

FIG. 4 is a fragmentary side sectional view of a Jamshidi needle with aK-wire, or guide wire, emerging from a through bore;

FIGS. 5A and 5B are enlarged fragmentary side views of one embodimenthaving a reformable end portion;

FIGS. 6A and 6B are enlarged side views of an end portion, expanded andunexpanded, of a further embodiment of a K-wire, or guide wire, of thepresent invention;

FIG. 7 is an enlarged side view of an end portion of a still furtherembodiment of a K-wire, or guide wire, of the present invention;

FIG. 8 is an enlarged side view of an end portion of a still furtherembodiment of a K-wire, or guide wire, of the present invention;

FIG. 9 is an enlarged side view of an end portion of an embodiment ofthe present invention similar to that shown in FIG. 2B;

FIG. 10 is an enlarged side view of an end portion of one embodiment ofthe present invention;

FIG. 11 is an enlarged side view of the embodiment illustrated in FIG.10 with the end portions spread apart;

FIG. 12 is an enlarged side view of one embodiment of the presentinvention;

FIG. 13 is an enlarged side view of one embodiment of the presentinvention;

FIG. 14 is a view of one embodiment of the present invention extendingthrough the cannula portion of a jamshidi needle;

FIG. 15A is an enlarged side view of one embodiment of the presentinvention;

FIG. 15B is an enlarged side view of one embodiment of the presentinvention;

FIG. 15C is an enlarged side view of one embodiment of the presentinvention;

FIG. 15D is an enlarged side view of one embodiment of the presentinvention;

FIG. 16 is an enlarged perspective view of one embodiment of the presentinvention;

FIG. 17 is an enlarged perspective view of one embodiment of the presentinvention;

FIG. 18 is an enlarged perspective view of one embodiment of the presentinvention;

FIG. 19 is an enlarged perspective view of one embodiment of the presentinvention;

FIG. 20 is an enlarged perspective view of one embodiment of the presentinvention;

FIG. 21 is an enlarged perspective view of one embodiment of the presentinvention;

FIG. 22 is a partial side view illustrating insertion of a Jamshidineedle into the pedicle of a human spine;

FIG. 23 is a partial side view illustrating the removal of the needlefrom within the jamshidi, leaving the cannulated portion in place withinthe bone;

FIG. 24 is a partial side view illustrating the insertion of the K-wire,or guide wire, of the instant invention into the through bore within thejamshidi;

FIG. 25 is a partial side view illustrating the K-wire, or guide wire,emerging from the distal end of the jamshidi into the bone anddeploying;

FIG. 26 is a partial side view illustrating the removal of the jamshidiand leaving the K-wire, or guide wire, in place within the bone in adeployed position;

FIG. 27 is an enlarged end view of another embodiment of the presentinvention; and

FIG. 28 is an enlarged perspective view of another embodiment of thepresent invention;

Like numbers used throughout the figures designate like or similar partsand/or construction.

DETAILED DESCRIPTION OF THE INVENTION

While the present invention is susceptible of embodiment in variousforms, there is shown in the drawings and will hereinafter be describedpresently preferred embodiments with the understanding that the presentdisclosure is to be considered an exemplification of the invention andis not intended to limit the invention to the specific embodimentsillustrated.

Referring generally to the figures, the reference numeral 10 designatesgenerally a K-wire, or guide wire, usable in surgical procedures incombination with a surgical tool such as a jamshidi needle 12, drill ortap (not shown), or a surgical device such as a screw, plate or implant.K-wires (also called Kirschner wires or guide wires) are well known inthe art. Jamshidi needles are also well known in the art, and have atubular member 148 with a through bore 16 (as would a drill, tap orscrew) and a removable and replaceable rod member 15 having a sharpeneddistal end 17. The rod member 15 is held in place within the throughbore by threads or a bayonet mount (not shown) as is known in the art. Ahandle 18 may also be provided at the proximal end 20 of the tubularmember 148 for facilitating insertion of the tubular member into asurgical site 21, such as a vertebra 22 with a pedicle 23 in a patientsuch as a human. A surgeon may manipulate the jamshidi needle 12 usingthe handle 18, and may also apply impact force to the tubular member 148by striking the handle 18 with a hand or impact tool such as a hammer149, as illustrated in FIG. 22. Jamshidi needles are used to penetratebone in the performance of a surgical procedure such as attaching ascrew 24 (FIG. 5B) to bone. A rod 15 may be installed in the throughbore 16 during hole formation to increase rigidity of the tubular member148. The rod 15 is removed to provide a through bore 16 for the K-wire10 insertion. After forming a hole 25 with the jamshidi needle 12, theK-wire, or guide wire 10, is inserted into the interior of the bone andthe jamshidi needle is removed, leaving the K-wire, or guide wire, inplace within the bone. In some surgical procedures, like spinal surgery,the K-wire, or guide wire, is inserted through one wall of a bone, e.g.,a pedicle 23, and is placed against an opposite bone wall. If care isnot taken during surgery, the K-wire, or guide wire, may be pushedthrough the opposing bone wall creating a risk of injury. The presentinvention is a solution to this potential problem.

The K-wire, or guide wire 10, is typically used as a pilot or guide forother surgical tools or devices such as drills, taps, plates, implantsand screws. In the attachment of a screw 24 (FIG. 5B), the screw canhave a through bore 44 that receives the K-wire, or guide wire, forguiding the screw to a hole 25 that was formed with the jamshidi andthereafter drilled and tapped using the K-wire, or guide wire as aguide. After installation of the screw 24, the K-wire, or guide wire 10,is then extracted through the through bore 44 of the screw 24 by simplypulling on the K-wire, or guide wire, to reduce the frontal area of theK-wire, or guide wire, substantially to its original size.

The K-wire, or guide wire 10, has opposite end portions 26, 28 and agenerally cylindrical intermediate portion 30 positioned between the endportions. The length of the K-wire, or guide wire 10, is preferably longenough to extend beyond both ends of the surgical tool being used, e.g.,a jamshidi needle 12. The K-wire, or guide wire 10, is sized and shapedto be freely movable along the through bore 16. The end portion 28 willbe referred to as the manipulative end, and the end portion 26 will bereferred to as the operative end for convenience. Preferably, the entirelength of the manipulative end portion 28 and the intermediate portion30 is generally cylindrical to facilitate removal of a tool or devicefrom an installed K-wire, or guide wire 10.

The operative end portion 26 is provided with a section 32 that iscontrollably deformable. The section 32 may be an integral portion ofthe K-wire, or guide wire 10, or attached thereto. Several differentsections 32 are described below. In general, the section 32 isconfigurable to fit within the through bore 16 and be freely movabletherein. The K-wire, or guide wire, is insertable into the through bore16 for insertion into the surgical site 21 for use and for removal froma through bore in the tool or device. The K-wire, or guide wire, mayalso be removed prior to a later surgical step if it is no longerneeded. For example, if the K-wire, or guide wire, is not needed toguide the screw 24 for insertion, it may be removed prior to attachingthe screw 24. When outside of the through bore 16, the operative end 26expands automatically or can be manually expanded to present an expandedface with a projected area greater than the transverse cross sectionalarea of the K-wire, or guide wire 10, while positioned in the throughbore 16. By way of example, the operative end 26 seen in FIG. 3 has aprojected area of approximately (given that the end 33 of the bend atthe intermediate section 30 of K-wire, or guide wire 10, is roundedreducing the area slightly) L times W whereas the K-wire, or guide wire,has a cross sectional area of A=πr² where r is equal to W/2. It ispreferred that the reconfigured cross sectional projected area be atleast about 1.5 times, and preferably at least about twice the size ofthe first cross sectional area of the K-wire, or guide wire, asdescribed below.

The K-wire, or guide wire 10, or the deformable portion 32 of theK-wire, or guide wire, may be made of a deformable material which willallow at least the operative end 26 to be configured between first andsecond configurations (see FIGS. 2A and 2B) with one configuration (FIG.2B) presenting a larger projected area than the first (FIG. 2A) asdiscussed above. One suitable reconfigurable material is referred to asa shape memory alloy such as Nitinol. A reversible, solid phasetransformation known as martensitic transformation is the force behindshape memory alloys. Such alloys are well known and form a crystalstructure, which is capable of undergoing a change from one form ofcrystal structure to another. Temperature change and/or loading caninitiate the shape transformation. By way of example, above itstransformation temperature, Nitinol is superelastic, able to withstanddeformation when a load is applied and return to its original shape whenthe load is removed. Below its transformation temperature, it displaysthe shape memory effect. When it is deformed below its transformationtemperature, it will remain in that shape until heated above itstransformation temperature, at which time it will return to its originalshape. The original shape would then be the bent form, and then it canbe reformed cold to straight. Upon heating, the bend will return. Theheat (or temperature increase) can be provided by contact with thepatient. Elastically deformable materials may also be used, such asspring steel with high yield strength where stress is induced to changea shape that is elastically released to change the shape of the deformedmember back to its non stressed shape. An embodiment of the invention isshown in FIGS. 5A and 5B that could be made using a spring material andis described below. Plastically deformable materials might also be usedfor some operative end portion 26 configurations. The terms resilientlydeformable, plastically deformable and spring are used generally toindicate a material property when the material is deformed duringtypical use of the K-wire, or guide wire, as described herein.Controlled bending can be induced by using controlled weak points, suchas a groove or the like, at selected strategic locations. The embodimentin FIGS. 5A and 5B might also be used with a plastically deformablematerial. The screw 24 or other tool or device that is anticipated to bethe last one used with the K-wire, or guide wire 10, may be providedwith a forcing cone 35 to help reconfigure the end portion 26 back toits unexpanded shape to conform it to fit within a passage like passages16, 44 for insertion or removal. An embodiment of this form is seen inFIGS. 5A and 5B and is described below.

In the embodiment shown in FIGS. 1-3, the operative end 26 has alaterally extending portion 36 when out of the through bore 16. Thedeformation to lateral extension may be provided as described above byapplying heat to effect bending from memory. The portion 36 may beprovided as a permanent bend in the K-wire, or guide wire 10, which canthen be deformed to straight by confinement in the through bore 16, andupon exit from the through bore will reassume its bent configuration.The material properties of the end portion 26 may be selected to providefor straightening of the bend for removal through a passage or borewhich may be facilitated, e.g., by the use of a forcing cone 35. Thelateral extension presents a larger projected area to further limitforward axial motion into the surgical site.

FIG. 4 shows a surgical tool configuration that can be used tofacilitate directing a K-wire, or guide wire 10, out of the through bore16. It uses a curved tip 37 to direct the exiting K-wire, or guide wire10.

In the embodiment shown in FIGS. 5A and 5B, the operative end 26 is inthe form of an expandable cage 40 having a plurality of rods 42 that canassume an expanded position. FIG. 5A illustrates a contractedconfiguration of cage 40 when in a through bore 16 of tubular member148. FIG. 5B illustrates the cage 40 in its expanded configuration and ascrew positioned on the K-wire, or guide wire 10. The embodiment ofFIGS. 5A and 5B may be constructed in at least two ways, resilientlydeformable rods 42 or plastically deformable rods 42. A memory metalalloy may be used. A polymeric material such as PEEK or the like mayalso be used for at least the rods 42. If the rods 42 are elasticallydeformable, they can be formed as biased to an outward or expandedconfiguration, where once outside of the through bore 16 they will moveoutwardly to relieve induced stress to provide the expandedconfiguration like in FIG. 5B. The rods 42 may also be plasticallydeformable, and upon application of axial force will move to an expandedposition as in FIG. 5B. When the K-wire, or guide wire, is in thethrough bore 16, the rods 42 assume, or are in the contractedconfiguration; and when the rods 42 are outside of the bore, they assumeor are forced into the expanded position, providing an increasedprojected area for engagement with material in the surgical site asdiscussed above. It is to be noted that the rods may also be made of amemory alloy as described above. The forcing cone 35 may be used tofacilitate removal of the K-wire, or guide wire 10, through the throughbore 44. The distal ends of the rods 42 may be held in place with an endcap 43. The projected area of the end portion 26 when expanded, as seenin FIG. 5B, would be that area defined or bounded by outermost extendingportions of the rods 42 as at portions 46.

FIGS. 6A and 6B illustrate another embodiment of the invention. FIG. 6Ashows an end portion 26 with an expandable end bulb 50 that may be madeout of a memory alloy, which upon heating assumes the expandedconfiguration illustrated in FIG. 6B. This embodiment is particularlyadapted for use when extraction of the K-wire, or guide wire, is otherthan through a tool or device passage.

FIG. 7 illustrates another embodiment of the invention. It utilizes apair of opposed legs 61, 62. The legs 61, 62 are constructed to move inan outward direction, either from spring action or from otherwisereassuming a formed shape, as from a spring type material or atemperature change as by using a memory alloy as described above. In theillustrated embodiment, the legs 61, 62 have overlying portions at 63.

FIG. 8 illustrates an additional embodiment of the invention and issimilar to the form shown in FIG. 7 by having two legs 71, 72, but thelegs do not overlap; rather, the legs diverge from a common area 73 andhave a gap 74 therebetween when in the extended position as shown.

The embodiments of the invention shown in FIGS. 6-8 may utilize a shank14 of one material and an end portion of another material such as aspring material, a memory alloy or a polymeric material.

FIG. 9 illustrates a still further embodiment of the present invention.It is similar to the K-wire, or guide wire 10, shown in FIGS. 2A and 2Band has a shank 14 with an attached end portion 26 having a singleextending free end portion 80 shown in its extended configuration. Thefree end 80 may be provided as a permanent bend in the K-wire, or guidewire 10, which can then be deformed to straight by confinement in thethrough bore 16, and upon exit from the passage will reassume its bentconfiguration. The material properties of the free end portion 80 may beselected to provide for straightening of the bend for removal through apassage which may be facilitated, e.g., by the use of a forcing cone.The lateral extension of the free end presents a larger projected areato further limit forward axial motion into the surgical site.

FIGS. 10 and 11 illustrate a still further embodiment of the presentinvention. The end portion 26 of the K-wire or guide wire includes aplurality of deformable ends, illustrated herein as independent legs 82and 84. The K-wire or guide wire of FIGS. 10 and 11 can be made from ashape memory alloy such as Nitinol. Other shape memory alloys andmaterials can also be used. The ends 82 and 84 are normally deformedoutwardly from the longitudinal axis 85 of the K-wire or guide wire at acommon area diverging point 87 as shown in FIG. 11 within the guidewire. As such, the deformable ends, or legs 82 and 84 form separatestructures which can move outwardly, independent of each other from thecommon area diverging point 87. The legs 82 and 84 are separated by agap 87 which runs the length of the legs 82 and 84 and is orientated ina generally parallel manner from the longitudinal axis 85 of the guidewire 10. The deflection of the ends 82 and 84 presents a larger endsurface area when the K-wire or guide wire is penetrating a bone. Thislarger end surface offers more resistance and consequently prevents theK-wire or guide wire from penetrating too far into the bone and perhapspassing into an adjacent bone or outside of the intended bone. Thelength of the ends 82 and 84 together with the different shape memoryalloys determine how quickly the ends 82 and 84 deform outwardly afterthey enter a bone. The more rapidly they deform, the less they penetrateinto a bone. The ends 82 and 84 collapse together, as shown in FIG. 10,when the K-wire or guide wire is withdrawn back through the Jamshidineedle. A groove 86 on end 82 permits projection 88 to fit therein whenin the collapsed position.

As further illustrated, the K-wire or guide wire 10 is shown with one ofthe deformable ends being longer than the opposing deformable end. Asillustrated, leg 82 is longer than leg 84. Leg 82 includes a tip portion89 that extends past and is bent inwardly towards the leg 84 to overlapa tip portion 91 of the shorter leg 84. While most of the leg 82 isorientated in a generally parallel manner relative to the leg 84, atleast a segment of, if not all of the tip portion 89 is positioned in aperpendicular orientation relative to the leg 84. A second gap 93separates the tip portions 89 and 91. The second gap 93 therefore isformed substantially perpendicular to the longitudinal axis 85 when legs82 and 84 are in the non-deployed or not separated state.

FIGS. 12 and 13 illustrate other embodiments of the present invention.These embodiments are variations of the embodiment illustrated in FIGS.10 and 11. In FIG. 12 the end 82 of the K-wire or guide wire bendsoutwardly at 90. Also, end 84 bends outwardly at 92. The bends 90 and 92are positioned within the legs 82 and 84 at some distance away from thecommon area diverging point 87, i.e. towards the tip portions 89 and 91.This embodiment permits the ends 82 and 84 to bend outwardly from thelongitudinal axis more rapidly than the embodiments of FIGS. 10 and 11.In FIG. 13, the end 82 bends outwardly at 94 and the end 84 bendsoutwardly at 96. Bends 94 and 96 are closer to the tip portions 89 and91. Thus, they permit the ends 82 and 84 to bend outwardly from thelongitudinal axis more rapidly than the bends 90 and 92 of FIG. 12. Thefaster the ends move away from the longitudinal axis, the less theK-wire or guide wire penetrates into the bone. Therefore, the embodimentof FIG. 13 would penetrate less into a bone than the embodiment of FIG.12. Also the embodiment of FIG. 12 would penetrate less into a bone thanthe embodiment of FIGS. 10 and 11.

FIGS. 15A-15D illustrate other embodiments of the present invention.These embodiments are variations of the embodiment illustrated in FIGS.10 through 14. These embodiments generally include variations in thelength of the free ends 102, 104, as well as variations in the locationand type of bend that cause the free ends to bend outwardly. Thesevariations, as well as variations in the diameter of the wire, permitsignificant control over the deployment of the device, e.g. increase infrontal area, as well as the devices engagement to the surrounding bone.The faster the ends move away from the longitudinal axis 116, the lessthe K-wire, or guide wire, penetrates into the bone and the moredifficult it is to force the device forward with respect to its originaldeployed position. In FIGS. 15A-15D the ends 102 and 104 of the K-wire,or guide wire 10, bend outwardly at radii 90 and 91 respectively. Thebend divides each free end 102, 104 into a first liner portion 95A, 95Band a second portion 97A, 97B. The second portions 97A, 97B diverge awayfrom the longitudinal axis 116 at the bend when in the deployed state.The radii 90, 91 of the preferred embodiment are about 12 millimeters(mm). However, it should be noted that the radii can vary between 0 mmand about 200 mm without departing from the scope of the invention. Inthe non-limiting embodiments illustrated in FIGS. 15A and 15B, the freeends 102, 104 are bent to an included separation angle 106 of about 30degrees, causing a frontal width 108 of about 4.7 mm in an unloadedcondition. Additionally, a free length 110 of the ends is providedbehind the bends 90 and 91 to allow additional flexibility to the freeends. In the preferred embodiment, the free length 110 is about 4 mm andthe groove width 112 is about 0.3 mm on a 1.45 mm diameter guide wire.It should be noted that the guide wire, or K-wire, may include anydiameter suitable for use as a guide wire or K-wire without departingfrom the scope of the invention. Additionally, gripper teeth 118 may beprovided on the inner surfaces of the free ends 102, 104 to furtherengage the bone or tissue if needed. The embodiments illustrated inFIGS. 15C and 15D are similar to the embodiments of FIGS. 15A and 15B.In these embodiments, the radius 90 is moved closer to the distal ends111,113 of the free ends 102, 104 and the included angle is increased toabout 50 degrees to allow deployment within tighter spaces within abone.

Referring to FIG. 16, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end 26 of the K-wire,or guide wire 10, includes a controllably deformable section 32 having arocker member 120 mounted therein for limited rotation about a pinmember 122. The rocker member 120 is preferably mounted to set within agroove 124 cut into the operative end 26 of the guide wire, or K-wire10, so that the guide wire, or K-wire, may be inserted through ajamshidi and be retracted through a cannulated implant. A control rod,spring member or shape memory member (not shown) may be utilized todeploy and/or retract the rocker member.

Referring to FIG. 17, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end 26 of the K-wire,or guide wire 10, includes a controllably deformable section 32comprising an expandable collet portion 126. The expandable colletportion includes a plurality of slits or grooves 128 between flexiblefingers 127 to allow an expansion member 130 to be activated bytemperature or a manually operated draw bar (not shown) to causecontrolled expansion of the collet portion, thereby increasing thefrontal area of the device. The collet portion is preferably formed froma spring or memory material so that the collet portion will returnsubstantially to its original shape when the draw bar or temperature ofthe expansion member is returned substantially to its original conditionfor retraction of the device from the surgical site.

Referring to FIG. 18, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end 26 of the K-wire,or guide wire 10, includes a controllably deformable section 32 having ashape memory or spring core material (not shown) coated with a polymericsheath 132.

Referring to FIG. 19, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end 26 of the K-wire,or guide wire 10, includes a controllably deformable section 32 having aplurality of vanes 134 constructed of shape memory or spring typematerial. In this embodiment, the manipulative end 26 of the guide wire,or K-wire, can be rotated in opposite directions about the longitudinalaxis 116 to deploy or retract the vanes on the operative end 26. Itshould be noted that while the vanes are illustrated as beingsubstantially straight along their length, they may be helical, curvedor otherwise shaped to allow the desired deployment and retractionwithout departing from the scope of the invention.

Referring to FIG. 20, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end 26 of the K-wire,or guide wire 10, includes a controllably deformable section 32 havingat least one, and more preferably two helically wound wire type members136 attached at a distal end to a central core member 138. In thisembodiment, the helical wire members may be constructed of a metalmaterial sufficiently rigid to allow the guide wire or K-wire to berotated, via the manipulative end, in a first direction into engagementwithin the bone and rotated in an opposite direction, via themanipulative end, to allow for the device to be removed from the bone.

Referring to FIG. 21, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end of the K-wire, orguide wire 10, includes a controllably deformable section 32 having fourbar linkage 140 connected at one corner pin 142. A draw bar or cable(not shown) may be utilized to controllably expand and contract the fourbar linkage to engage and release the bone.

The present invention also includes a method of conducting a medicalprocedure using a K-wire, or guide wire, as illustrated in FIG. 14. Asurgeon or other medical personnel places a surgical tool such as ajamshidi 12 at the surgical site. The initial surgical tool preferablyhas a guiding through bore opening at the distal tool end such as thatdescribed above for a jamshidi needle 12. The jamshidi 12 is tapped orpressed into the bone at the desired angle as illustrated in FIG. 22.The needle portion of the jamshidi is then removed from the through boreas illustrated in FIG. 23 and a K-wire, or guide wire 10, is guided tothe site by passing the K-wire, or guide wire, through the through bore16 until the operative end 26 extends beyond the open end of the throughbore 16. See FIG. 24. The jamshidi may include a lead in funnel 98 tohelp the surgeon place the K-wire, or guide wire, into the Jamshidineedle. The operative end 26 of the K-wire, or guide wire, has at leasta portion deformed after its exit from the through bore 16, such thatthe deformed portion presents a projected area greater than the crosssectional area of the K-wire, or guide wire, when in the through bore 16as described above. See FIG. 25. The deformation can occurautomatically, as by increasing the temperature of the operative endportion 26, when it includes a memory metal alloy. The deformation mayalso be induced by relieving stress induced into the operative endportion, as when the deformable portion is constructed of a springmaterial. The deformation may also be induced mechanically by theapplication of an axially directed force along the K-wire, or guide wire10. After at least a portion of the surgery, the K-wire, or guide wire,can be removed as described above. The K-wire, or guide wire, is used toguide surgical tools and/or devices to the surgical site during thesurgical procedure. Once the K-wire, or guide wire, has been insertedinto the bone, the jamshidi needle can be withdrawn and a cannulated tapor other instrument can be slid down the K-wire, or guide wire, andinserted into the bone. When the tap reaches the expanded ends 82, 84 ofthe K-wire, it may stop its forward progress. Thus, this inventionavoids the need for fluoroscopy to determine the position of the tap orother instrument in a bone.

FIG. 27 illustrates a further embodiment of the present invention. AK-wire or guide wire 10 is similar to the K-wire or guide wiresillustrated in FIGS. 15A-15D. The K-wire has an operative end portion 26which includes a portion 152 which has been swaged down to a smallerdiameter. The end of the K-wire 10 includes ends 102 and 104, similar tothe ends of the embodiment of FIGS. 15A-15D. The ends 102 and 104 areformed from a material, such as a shape memory alloy, which permits theends 102 and 104 to bend outwardly, as illustrated. The end 154 oftubular member 148 can be conically tapered, as illustrated. End 154prevents the K-wire from completely exiting the tubular member 148. Thisis because the inner diameter of the tapered end 154 is smaller that thediameter of the K-wire before it has been swaged down to a smallerdiameter. End 154 can also be provided with grooves or notches whichenable the tube to readily cut or drill into a bone or similar material.Once the desired depth or location is achieved, the drills, taps,screws, etc. can be slid into place by sliding them down over tube 148.

Referring to FIG. 28, an alternative embodiment of the present inventionis illustrated. In this embodiment, the operative end 26 of the K-wireor guide wire 10, includes a controllably deformable section 158 havingone helically wound wire type member 160 attached to the operative end26 of the K-wire 10. In this embodiment, the helical wire 160 may beconstructed of a metal material sufficiently rigid to allow the K-wireto be rotated, via the manipulative end, in a first direction intoengagement with the bone and rotated in an opposite direction, via themanipulative end, to allow for the device to be removed from the bone.

It is to be understood that while certain forms of the invention areillustrated, it is not to be limited to the specific forms orarrangements herein described and shown.

It will be apparent to those skilled in the art that various changes maybe made without departing from the scope of the invention and theinvention is not to be considered limited to what is shown and describedin the specification and any drawings/figures included herein.

One skilled in the art will readily appreciate that the presentinvention is well adapted to carry out the objectives and obtain theends and advantages mentioned, as well as those inherent therein. Theembodiments, methods, procedures and techniques described herein arepresently representative of the preferred embodiments, are intended tobe exemplary and are not intended as limitations on the scope. Changestherein and other uses will occur to those skilled in the art which areencompassed within the spirit of the invention and are defined by thescope of the appended claims. Although the invention has been describedin connection with specific preferred embodiments, it should beunderstood that the invention as claimed should not be unduly limited tosuch specific embodiments. Indeed, various modifications of thedescribed modes for carrying out the invention which are obvious tothose skilled in the art are intended to be within the scope of thefollowing claims.

What is claimed is:
 1. A method of conducting a medical procedure on asurgical site using a guide wire, the method comprising the steps of:placing a surgical tool at a surgical site, said surgical tool having aguiding through bore which terminates in a distal end opening; passing aguide wire having a manipulative end, a center portion and an operativeend through said guiding through bore, said operative end configured tobe traversable between a first configuration and a second configurationconfigured to limit forward axial motion of said guide wire into saidsurgical site; and traversing said guide wire from said firstconfiguration to said second configuration by passing said guide wireoperative end beyond said opening of said through bore, said secondconfiguration defined by said operative end having a deformed projectedarea that is greater than the cross sectional area of the guide wirewhen in said first configuration, wherein said operative end includestwo equally sized deployable free ends which diverge from a commonregion of said guide wire, each said free end having a first linearportion and a second portion which diverges from the longitudinal axisof said guide wire at a bend, said bend positioned between said commonregion of said guide wire and a distal end of said free end, whereineach said bend is positioned at a predetermined location within saidfree end to provide a predetermined separation angle, wherein each saidfree end contains at least one bone or tissue engagement member.
 2. Themethod of conducting a medical procedure on a surgical site using aguide wire according to claim 1 further including the step of traversingsaid guide wire from said second configuration to said firstconfiguration by retracting said guide wire from said surgical site,whereby retracting said operative end from a position extending pastsaid opening of said surgical tool to a position within said throughbore results in a cross sectional area that is less than the area ofsaid projected area when in said second configuration.
 3. The method ofconducting a medical procedure on a surgical site using a guide wireaccording to claim 1 wherein said treatment site is bone or bone tissue.4. The method of conducting a medical procedure on a surgical site usinga guide wire according to claim 1 wherein said tissue engagement memberincludes a plurality of teeth provided on an inner surface of the freeend.
 5. The method of conducting a medical procedure on a surgical siteusing a guide wire according to claim 1 wherein said bend of each saidfree end is positioned closer to said distal end of said free end. 6.The method of conducting a medical procedure on a surgical site using aguide wire according to claim 1 wherein said bend of each said free endis positioned closer to said point where said free ends diverge from acommon region of said guide wire.
 7. The method of conducting a medicalprocedure on a surgical site using a guide wire according to claim 1wherein each said bend is positioned at a predetermined location withinsaid free ends to provide an angle of at least 30 degrees.
 8. The methodof conducting a medical procedure on a surgical site using a guide wireaccording to claim 1 wherein each said bend is positioned at apredetermined location within said free ends to provide an angle of atleast 50 degrees.
 9. The method of conducting a medical procedure on asurgical site using a guide wire according to claim 1 wherein each saidfree end is constructed from a flexible material.
 10. The method ofconducting a medical procedure on a surgical site using a guide wireaccording to claim 1 wherein each said free end is constructed from amemory metal alloy.
 11. The method of conducting a medical procedure ona surgical site using a guide wire according to claim 1 wherein saidmemory metal alloy is a super-elastic material.
 12. The method ofconducting a medical procedure on a surgical site using a guide wireaccording to claim 1 wherein the memory metal alloy includes Nitinol.13. The method of conducting a medical procedure on a surgical siteusing a guide wire according to claim 1 wherein each said deployable endis constructed from a memory metal alloy.
 14. The method of conducting amedical procedure on a surgical site using a guide wire according toclaim 1 wherein each said deployable end is constructed of a resilientlydeformable spring material.
 15. The method of conducting a medicalprocedure on a surgical site using a guide wire according to claim 1wherein each said deployable end has a deformable portion made of aplastically deformable material.
 16. The method of conducting a medicalprocedure on a surgical site using a guide wire according to claim 1wherein each said free end is self deployable.